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Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.
The title of this article is deliberatively provocative. Pharmacopoeias contain the legal standards for the quality of medicines with monographs for active ingredients, excipients, and finished products. Analysts should understand how a monograph, together with the associated general notices and general chapters, relates to their responsibilities under good manufacturing practices for ensuring data integrity. However, many pharmacopeial tests therein involve classical chemical analysis (e.g., color, appearance, titration) and rely on an analyst’s observation with little, if any, documented evidence for review. Hence, do pharmacopoeias inadvertently facilitate data integrity violations?
In this article the authors look at the following topics:
C. Burgess is managing director of Burgess Analytical Consultancy Limited and is the writer of the Statistical Solutions column in Pharmaceutical Technology. R.D. McDowall is director of R D McDowall Limited and is the author of Questions of Quality and Focus on Quality columns in LC-GC Europe and Spectroscopy, respectively.
eBook: Regulatory Sourcebook, October 2020
When referring to this article, please cite it as C. Burgess and R.D. McDowall, “Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?" BioPharm International Regulatory Sourcebook (October 2020).